Relapsing-Remitting Multiple SclerosisPhase 3CONFIRMNCT00451451

Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis

A Phase 3 study testing BG00012 and Glatiramer Acetate in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 195 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get… Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Relapsing-Remitting Multiple Sclerosis
What is being tested?: BG00012 and Glatiramer Acetate
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,417 participants
Where: 195 sitesin 28 countries
Study dates: Jun 2007to Aug 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Must have confirmed diagnosis of RRMS according to McDonald criteria #1-4
Must have a baseline EDSS between 0.0 and 5.0, inclusive.
Must have relapsing-remitting disease course.

Who cannot join

Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
Pregnant or nursing women
Note: Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

195 sites in 28 countries.

Country

City, postcode or hospital

195 sites in 28 countries

United States72 sites

Research Site
Amherst, New York
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Augusta, Georgia
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Baltimore, Maryland
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Bellevue, Ohio
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Birmingham, Alabama
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Boston, Massachusetts
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Boulder, Colorado
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Buffalo, New York
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Burlington, Vermont
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Cedarhurst, New York
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Charlotte, North Carolina
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Cleveland, Ohio
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Clinton Township, Michigan
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Colorado Springs, Colorado
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Columbus, Georgia
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Columbus, Ohio
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Cordova, Tennessee
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Cullman, Alabama
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Dallas, Texas
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Dover, New Hampshire
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Edmond, Oklahoma
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Eugene, Oregon
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Fort Collins, Colorado
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Franklin, Tennessee
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Freehold, New Jersey
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Galveston, Texas
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Grand Rapids, Michigan
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Houston, Texas
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Huntsville, Alabama
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Indianapolis, Indiana
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Kansas City, Kansas
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Knoxville, Tennessee
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La Jolla, California
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Lebanon, New Hampshire
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Loma Linda, California
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Louisville, Kentucky
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Madison, Wisconsin
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Maitland, Florida
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Medford, Oregon
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Memphis, Tennessee
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Meridan, Idaho
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Miami, Florida
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Milwaukee, Wisconsin
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Mineola, New York
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Naples, Florida
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Nashville, Tennessee
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Pasadena, California
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Patchogue, New York
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Pittsburgh, Pennsylvania
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Plainview, New York
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Pompano Beach, Florida
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Portland, Oregon
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Richmond, Virginia
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Round Rock, Texas
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Sacramento, California
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Salt Lake City, Utah
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San Antonio, Texas
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Sarasota, Florida
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Seattle, Washington
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Shreveport, Louisiana
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Souderton, Pennsylvania
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St. Petersburg, Florida
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Staten Island, New York
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Stony Brook, New York
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Tacoma, Washington
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Tallahassee, Florida
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Tampa, Florida
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Teaneck, New Jersey
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Walnut Creek, California
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Winston-Salem, North Carolina

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About this study

Official title: A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis

Other objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS. Additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.

Read the detailed description

Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects approximately 400,000 persons in North America and 365,000 persons in Europe. It is predominantly a disease of young adults, primarily women, with disease onset typically occurring between the ages of 20 and 40.

Conditions: Relapsing-Remitting Multiple Sclerosis
Being tested: BG00012, Placebo, Glatiramer Acetate
Keywords: relapsing, multiple sclerosis, oral, remitting
Medical subject headings: Multiple Sclerosis, Relapsing-Remitting, Recurrence, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BG00012Drug
Also called dimethyl fumarate, Tecfidera®
PlaceboDrug
Glatiramer AcetateDrug

Study groups in NCT00451451
Study group	Role	What they receive
BG00012 240 mg Twice Daily (BID)	Experimental	Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD) Receives: Drug: BG00012; Drug: Placebo
BG00012 240 mg 3 Times Daily (TID)	Experimental	Participants received two 120 mg BG00012 capsules orally three times daily (TID) Receives: Drug: BG00012
Placebo	Placebo comparator	Participants received two placebo capsules orally three times daily (TID) Receives: Drug: Placebo
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)	Active comparator	Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD) Receives: Drug: Glatiramer Acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

Annualized Relapse Rate
A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee.
The adjusted annualized relapse rate was calculated from a negative binomial regression model , adjusted for baseline Expanded Disability Status Scale (EDSS ) score(≤2.0 versus>2.0), age (<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment.
Measured: 2 years

Secondary outcomes (4)

Number of New or Newly Enlarging T2 Hyperintense Lesions
The number of new or newly enlarging T2 hyperintense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T2 hyperintense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T2 hyperintense lesion volume.
Measured: 2 years
Number of New T1 Hypointense Lesions
The number of new T1 hypointense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T1 hypointense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T1 hypointense lesion volume.
Measured: 2 years
Proportion of Subjects Relapsed
A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution.
Measured: 2 years
Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)
EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Scores range from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as ≥ 1.0 point increase in subjects with a baseline EDSS of ≥1.0, or ≥1.5 point increase in subjects with a baseline EDSS=0, and required that the increase from baseline was confirmed ≥ 12weeks later. The proportion of subjects with confirmed (12-week) disability progression was estimated using the Kaplan-Meier method, which was based on the time-to-first-progression survival distribution
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Aug 2011

First posted23 Mar 2007 (estimated)
Study startJun 2007
Primary completionAug 2011
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
More trials run by BiogenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,417 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00451451
Sponsor's protocol ID: 109MS302
Acronym: CONFIRM
Status last verified: Jan 2015
First submitted: 21 Mar 2007
Last updated: 26 Jan 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Amezcua L, Mao-Draayer Y, Vargas WS, Farber R, Schaefer S, Branco F, England SM, Belviso N, Lewin JB, Mendoza JP, Shankar SL; ENDORSE Study Investigators. Efficacy of Dimethyl Fumarate in Young Adults with Relapsing-Remitting Multiple Sclerosis: Analysis of the DEFINE, CONFIRM, and ENDORSE Studies. Neurol Ther. 2023 Jun;12(3):883-897. doi: 10.1007/s40120-023-00475-8. Epub 2023 Apr 15.
PubMed 37061656
Gold R, Arnold DL, Bar-Or A, Fox RJ, Kappos L, Chen C, Parks B, Miller C. Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years' follow-up of DEFINE, CONFIRM, and ENDORSE. Ther Adv Neurol Disord. 2020 May 12;13:1756286420915005. doi: 10.1177/1756286420915005. eCollection 2020.
PubMed 32426039
Mehta D, Miller C, Arnold DL, Bame E, Bar-Or A, Gold R, Hanna J, Kappos L, Liu S, Matta A, Phillips JT, Robertson D, von Hehn CA, Campbell J, Spach K, Yang L, Fox RJ. Effect of dimethyl fumarate on lymphocytes in RRMS: Implications for clinical practice. Neurology. 2019 Apr 9;92(15):e1724-e1738. doi: 10.1212/WNL.0000000000007262. Epub 2019 Mar 27.
PubMed 30918100
Fox RJ, Gold R, Phillips JT, Okwuokenye M, Zhang A, Marantz JL. Efficacy and Tolerability of Delayed-release Dimethyl Fumarate in Black, Hispanic, and Asian Patients with Relapsing-Remitting Multiple Sclerosis: Post Hoc Integrated Analysis of DEFINE and CONFIRM. Neurol Ther. 2017 Dec;6(2):175-187. doi: 10.1007/s40120-017-0077-5. Epub 2017 Aug 2.
PubMed 28770420
Fernandez O, Giovannoni G, Fox RJ, Gold R, Phillips JT, Potts J, Okwuokenye M, Marantz JL. Efficacy and Safety of Delayed-release Dimethyl Fumarate for Relapsing-remitting Multiple Sclerosis in Prior Interferon Users: An Integrated Analysis of DEFINE and CONFIRM. Clin Ther. 2017 Aug;39(8):1671-1679. doi: 10.1016/j.clinthera.2017.06.012. Epub 2017 Jul 25.
PubMed 28751099
Fox RJ, Chan A, Zhang A, Xiao J, Levison D, Lewin JB, Edwards MR, Marantz JL. Comparative effectiveness using a matching-adjusted indirect comparison between delayed-release dimethyl fumarate and fingolimod for the treatment of multiple sclerosis. Curr Med Res Opin. 2017 Feb;33(2):175-183. doi: 10.1080/03007995.2016.1248380. Epub 2016 Nov 10.
PubMed 27733070
Gold R, Giovannoni G, Phillips JT, Fox RJ, Zhang A, Marantz JL. Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies. Neurol Ther. 2016 Jun;5(1):45-57. doi: 10.1007/s40120-016-0042-8. Epub 2016 Mar 1.
PubMed 26932146
Giovannoni G, Gold R, Fox RJ, Kappos L, Kita M, Yang M, Sarda SP, Zhang R, Viglietta V, Havrdova E. Relapses Requiring Intravenous Steroid Use and Multiple-Sclerosis-related Hospitalizations: Integrated Analysis of the Delayed-release Dimethyl Fumarate Phase III Studies. Clin Ther. 2015 Nov 1;37(11):2543-51. doi: 10.1016/j.clinthera.2015.09.011. Epub 2015 Oct 31.
PubMed 26526385
Fox RJ, Kita M, Cohan SL, Henson LJ, Zambrano J, Scannevin RH, O'Gorman J, Novas M, Dawson KT, Phillips JT. BG-12 (dimethyl fumarate): a review of mechanism of action, efficacy, and safety. Curr Med Res Opin. 2014 Feb;30(2):251-62. doi: 10.1185/03007995.2013.849236. Epub 2013 Oct 22.
PubMed 24131282
Fox RJ, Miller DH, Phillips JT, Hutchinson M, Havrdova E, Kita M, Yang M, Raghupathi K, Novas M, Sweetser MT, Viglietta V, Dawson KT; CONFIRM Study Investigators. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1087-97. doi: 10.1056/NEJMoa1206328.
PubMed 22992072

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
ClinicalTrials.gov ID: NCT00451451
Acronym / sponsor ID: CONFIRM / 109MS302
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: relapsing, multiple sclerosis, oral, remitting
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,417 participants (actual)
Lead sponsor: BiogenIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 23 Mar 2007 (estimated)
Results: Posted 2 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
BG00012 240 mg Twice Daily (BID)	Experimental	Drug: BG00012, Drug: PlaceboParticipants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
BG00012 240 mg 3 Times Daily (TID)	Experimental	Drug: BG00012Participants received two 120 mg BG00012 capsules orally three times daily (TID)
Placebo	Placebo comparator	Drug: PlaceboParticipants received two placebo capsules orally three times daily (TID)
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)	Active comparator	Drug: Glatiramer AcetateParticipants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Must have confirmed diagnosis of RRMS according to McDonald criteria #1-4
Must have a baseline EDSS between 0.0 and 5.0, inclusive.
Must have relapsing-remitting disease course.

Key exclusion criteria (3 listed)

Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
Pregnant or nursing women
Note: Other protocol-defined inclusion/exclusion criteria may apply.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BG00012Also: dimethyl fumarate, Tecfidera®	Drug	BG00012 240 mg 3 Times Daily (TID), BG00012 240 mg Twice Daily (BID)
Placebo	Drug	BG00012 240 mg Twice Daily (BID), Placebo
Glatiramer Acetate	Drug	Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)

Primary outcome

Annualized Relapse Rate
Time frame: 2 years
A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The adjusted annualized relapse rate was calculated from a negative binomial regression model , adjusted for baseline Expanded Disability Status Scale (EDSS ) score(≤2.0 versus>2.0), age (<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment.

4 secondary outcomes

Number of New or Newly Enlarging T2 Hyperintense Lesions
Time frame: 2 years
Number of New T1 Hypointense Lesions
Time frame: 2 years
Proportion of Subjects Relapsed
Time frame: 2 years
Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)
Time frame: 2 years

Results and safety

Results posted to the registry on 2 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	363	278
BG00012 240 mg Twice Daily (BID)	359	284
BG00012 240 mg 3 Times Daily (TID)	345	273
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)	350	292

Primary outcome: Annualized Relapse Rate

Time frame: 2 years. Mean (95% Confidence Interval). Unit: Relapses Per Year

Measure	Placebo n = 363	BG00012 240 mg Twice Daily (BID) n = 359	BG00012 240 mg 3 Times Daily (TID) n = 345	Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) n = 350
Value	0.401 (0.329 to 0.488)	0.224 (0.179 to 0.282)	0.198 (0.156 to 0.252)	0.286 (0.232 to 0.353)

Population analysed: The intent-to-treat (ITT) population was defined as all subjects who were randomized and received at least 1 dose of study treatment. Among subjects who switched to an alternative therapy for multiple sclerosis, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	79 of 363 (21.8%)	332 of 363 (91.5%)	Not reported
BG00012 240 mg Twice Daily (BID)	61 of 359 (17%)	336 of 359 (93.6%)	Not reported
BG00012 240 mg 3 Times Daily (TID)	54 of 344 (15.7%)	316 of 344 (91.9%)	Not reported
Total BG00012	115 of 703 (16.4%)	652 of 703 (92.7%)	Not reported
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)	60 of 351 (17.1%)	303 of 351 (86.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37061656Amezcua L, Mao-Draayer Y, Vargas WS, Farber R, Schaefer S, Branco F, England SM, Belviso N, Lewin JB, Mendoza JP, Shankar SL; ENDORSE Study Investigators. Efficacy of Dimethyl Fumarate in Young Adults with Relapsing-Remitting Multiple Sclerosis: Analysis of the DEFINE, CONFIRM, and ENDORSE Studies. Neurol Ther. 2023 Jun;12(3):883-897. doi: 10.1007/s40120-023-00475-8. Epub 2023 Apr 15.
Derived from this study: PubMed 32426039Gold R, Arnold DL, Bar-Or A, Fox RJ, Kappos L, Chen C, Parks B, Miller C. Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years' follow-up of DEFINE, CONFIRM, and ENDORSE. Ther Adv Neurol Disord. 2020 May 12;13:1756286420915005. doi: 10.1177/1756286420915005. eCollection 2020.
Derived from this study: PubMed 30918100Mehta D, Miller C, Arnold DL, Bame E, Bar-Or A, Gold R, Hanna J, Kappos L, Liu S, Matta A, Phillips JT, Robertson D, von Hehn CA, Campbell J, Spach K, Yang L, Fox RJ. Effect of dimethyl fumarate on lymphocytes in RRMS: Implications for clinical practice. Neurology. 2019 Apr 9;92(15):e1724-e1738. doi: 10.1212/WNL.0000000000007262. Epub 2019 Mar 27.
Derived from this study: PubMed 28770420Fox RJ, Gold R, Phillips JT, Okwuokenye M, Zhang A, Marantz JL. Efficacy and Tolerability of Delayed-release Dimethyl Fumarate in Black, Hispanic, and Asian Patients with Relapsing-Remitting Multiple Sclerosis: Post Hoc Integrated Analysis of DEFINE and CONFIRM. Neurol Ther. 2017 Dec;6(2):175-187. doi: 10.1007/s40120-017-0077-5. Epub 2017 Aug 2.
Derived from this study: PubMed 28751099Fernandez O, Giovannoni G, Fox RJ, Gold R, Phillips JT, Potts J, Okwuokenye M, Marantz JL. Efficacy and Safety of Delayed-release Dimethyl Fumarate for Relapsing-remitting Multiple Sclerosis in Prior Interferon Users: An Integrated Analysis of DEFINE and CONFIRM. Clin Ther. 2017 Aug;39(8):1671-1679. doi: 10.1016/j.clinthera.2017.06.012. Epub 2017 Jul 25.
Derived from this study: PubMed 27733070Fox RJ, Chan A, Zhang A, Xiao J, Levison D, Lewin JB, Edwards MR, Marantz JL. Comparative effectiveness using a matching-adjusted indirect comparison between delayed-release dimethyl fumarate and fingolimod for the treatment of multiple sclerosis. Curr Med Res Opin. 2017 Feb;33(2):175-183. doi: 10.1080/03007995.2016.1248380. Epub 2016 Nov 10.
Derived from this study: PubMed 26932146Gold R, Giovannoni G, Phillips JT, Fox RJ, Zhang A, Marantz JL. Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies. Neurol Ther. 2016 Jun;5(1):45-57. doi: 10.1007/s40120-016-0042-8. Epub 2016 Mar 1.
Derived from this study: PubMed 26526385Giovannoni G, Gold R, Fox RJ, Kappos L, Kita M, Yang M, Sarda SP, Zhang R, Viglietta V, Havrdova E. Relapses Requiring Intravenous Steroid Use and Multiple-Sclerosis-related Hospitalizations: Integrated Analysis of the Delayed-release Dimethyl Fumarate Phase III Studies. Clin Ther. 2015 Nov 1;37(11):2543-51. doi: 10.1016/j.clinthera.2015.09.011. Epub 2015 Oct 31.
Derived from this study: PubMed 24131282Fox RJ, Kita M, Cohan SL, Henson LJ, Zambrano J, Scannevin RH, O'Gorman J, Novas M, Dawson KT, Phillips JT. BG-12 (dimethyl fumarate): a review of mechanism of action, efficacy, and safety. Curr Med Res Opin. 2014 Feb;30(2):251-62. doi: 10.1185/03007995.2013.849236. Epub 2013 Oct 22.
Derived from this study: PubMed 22992072Fox RJ, Miller DH, Phillips JT, Hutchinson M, Havrdova E, Kita M, Yang M, Raghupathi K, Novas M, Sweetser MT, Viglietta V, Dawson KT; CONFIRM Study Investigators. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1087-97. doi: 10.1056/NEJMoa1206328.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Biogen

195 sites in 28 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BG00012 and Glatiramer Acetate in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 195 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 195 sites in United States, Germany, India, Mexico, Poland and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized Relapse Rate (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00451451, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2015.